Drugs

High-Risk Issue With Angiographic Syringes in Surgical Kits: FDA

FDA has issued an early alert warning healthcare providers about a potentially dangerous defect in certain angiographic syringes included in medical convenience kits, citing risks that could lead to serious injury or death.

The alert highlights a problem involving syringes distributed by Aligned Medical Solutions and manufactured by Medline Industries. The affected devices — known as Namic angiographic control syringes with rotating adapters — are used in procedures requiring precise fluid delivery, including angiography.

According to FDA, the rotating adapter on the syringes can unwind during use, potentially causing a loose connection or complete disconnection between the syringe and attached tubing. Such failures could result in blood loss, infection, or exposure to biohazards. In the most serious cases, air could enter the line, leading to an air embolism — a potentially life-threatening condition.

Medline has reported four serious injuries linked to the issue as of 3/13, though no deaths have been confirmed.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome